Federal Register notice: FDA seeks comments on an information collection extension for abbreviated new animal drug applications.
A CDER chart says that avoiding the most common manufacturing deficiencies can improve the quality of ANDA applications and thus the number of first-c...
Barrons identifies five issues facing FDA in the next few months that will shed light on how commissioner Robert Califf approaches his job and the age...
FDA plans several pilot programs to evaluate ways to improve foreign inspections.
FDA substantively denies a Novartis due diligence petition because the company failed to demonstrate that Regenxbio did not act with due diligence dur...
FDA grants fast track designation for 7 Hills Pharmas lead clinical-stage immunosuppressant to treat some malignant melanomas.
FDA and the Reagan-Udall Foundation announce a 3/29 virtual public workshop to discuss critical questions around access to naloxone and its use to rev...
Despite a statutory mandate, researchers say FDA has not increased post-approval trials with clinical endpoints for high-risk cardiovascular medical d...